OTC PPIs not likely to increase fracture risk, says FDA

June 26, 2011

Short-term use of over-the-counter (OTC) proton pump inhibitors (PPIs) probably does not pose an increased risk for hip, spine, and wrist fractures, according to the U.S. Food and Drug Administration (FDA). In May 2010, the FDA announced that PPI labeling would be revised to include a warning about a possible increased risk of fractures.

Short-term use of over-the-counter (OTC) proton pump inhibitors (PPIs) probably does not pose an increased risk for hip, spine, and wrist fractures, according to the U.S. Food and Drug Administration (FDA). In May 2010, the FDA announced that PPI labeling would be revised to include a warning about a possible increased risk of fractures.
     Further FDA review of several epidemiologic studies, however, showed that “those at greatest brisk for these fractures received high doses” of PPIs (not available OTC) or used them for 1 year or more. The increased risk of fracture occurred primarily in individuals aged 50 years or older.